Sun Shield Spf 50
FDA Label NDC 62742-4161

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs Inc for the product Sun Shield Spf 50 (NDC 62742-4161). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients:

Zinc Oxide - 8.6%

Titanium Dioxide - 6.5%

Otc - Purpose

Purpose: Sunscreen

Indications & Usage

Uses: Helps prevent sunburn. If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

Keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

If product is swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions:

  • Apply liberally 15 minutes prior to sun exposure.
  • Reapply: after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in sun sun, especially from 10 am - 2 pm.
  • wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.

Inactive Ingredient

Water (Aqua), Cyclopenatasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclotetrasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Alminum Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Glycerin, Sodium Chloride, Polyglyceryl-4 Isostearate, Vitis Vinifera, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Cetearyl Olivate, Sorbitan Olivate, Cyclohexasiloxane, Tocopherol, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Dimethicone/Polyglycerin-3 Crosspolymer, Isomalt, Dimethicone / Vinyl Dimethicone Crosspolymer Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Ethylhexyl Palmitate, Silica Dimethyl Silylate, Butylene Glycol, Sodium Hyaluronate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, PEG-8, Ascorbic Acid, Ascorbyl Palmitate, Citric Acid, Sodium Benzoate.

Other Safety Information

Protect this product from excessive heat and direct sun.

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